GENEVAX-HIV (APL 400-003) CANDIDATE DNA VACCINE--PILOT DOSE

先前的研究表明，一种成功的HIV疫苗需要诱导广泛的体液和细胞免疫反应。具体来说，诱导1类mhc限制性细胞毒性T淋巴细胞和中和可能针对多种病毒抗原的抗体反应是设计第二代候选艾滋病疫苗的重要目标。这是首次在HIV阴性志愿者中使用Biojector 2000系统评估APL 400-003 HIV DNA疫苗的安全性、耐受性和免疫应答的研究。该项目的主要目的是确定100 ug和300 ug剂量水平的Genevax HIV (APL 400-003) DNA质粒疫苗的多次肌肉注射是否能引起HIV-1抗原特异性刺激HIV阴性免疫系统。此外，确定是否存在以hiv特异性抗体、T辅助细胞和细胞毒性T淋巴细胞的产生为特征的多方面免疫反应；在适当条件下，可预防人体免疫缺陷病毒的感染或延缓疾病的进展。

Previous studies have suggested that a successful HIV vaccine will need to induce both broad humoral and cellular immune responses. Specifically, induction of class 1 MHC-restricted cytotoxic T lymphocytes and neutralizing antibody responses possibly against a number of viral antigens are important objectives in the design of second generation candidate AIDS vaccines. This is the first study in HIV-negative volunteers to evaluate safety, tolerance and immune response of APL 400-003 HIV DNA Vaccine using the Biojector 2000 system. The primary purpose of this project is to determine whether multiple intramuscular injections of the Genevax HIV (APL 400-003) DNA plasmid vaccine at dose levels of 100 ug and 300 ug can provoke an HIV-1 antigen-specific stimulation of the HIV negative immune system. Also, to determine if a multifaceted immune response characterized by production of HIV-specific antibodies, T helper cells and cytotoxic T lymphocytes; and which, under the appropriate conditions, may protect against infection by the Human Immunodeficiency Virus or delay the progression of disease.